FDA tries again to find balance between corrective cigarette warnings statements and 1st Amendment

The U.S. Food and Drug Administration is requesting public comment again on potential corrective warnings statements for traditional cigarettes, including providing 15 revised statements.

The FDA issued the public-comment notification Tuesday on the Federal Register website.

The goal is choosing survey participants from an internet panel of at least 1.2 million adolescents, young adults and older adults. Comments will be taken through Oct. 19. It has not indicated how individuals can participate.

“The study will collect data from various groups of consumers, including: adolescent current cigarette smokers; adolescents who are susceptible to initiation of cigarette smoking; young adult (ages 18 to 24) current cigarette smokers; and older adult current cigarette smokers,” the FDA said in its notice.

“The results will inform the agency’s development of cigarette graphic health warnings to be tested in future studies with the goal of implementing the mandatory graphic warning label statement” consistent with federal law and the First Amendment, the FDA said.

R.J. Reynolds Tobacco Co. declined to comment on the FDA initiative.

U.S. District Judge Gladys Kessler ruled in 2006 that cigarette manufacturers had concealed the dangers of smoking for decades. The U.S. Justice Department filed a civil case in 1999 under the federal Racketeer Influenced and Corrupt Organizations law, or RICO.

Part of Kessler’s ruling was a requirement that tobacco manufacturers include corrective statements on their products.

On April 25, the U.S. Court of Appeals for the District of Columbia Circuit reaffirmed that manufacturers must meet that requirement.

However, the judges also ruled that the statements cannot include the phrase “here is the truth.”

The manufacturers have argued that the “here is the truth tagline conveys the unambiguous message that defendants have previously withheld ‘the truth’ about the effects of smoking” because they would have been ordered to include the tagline.

The court wrote that “because courts do not ordinarily order companies to disseminate information absent prior wrongdoing, defendants allege that this phrase communicates that they are being compelled to speak as punishment for prior wrongdoing.”

The court said it agreed that “read together, these two phrases most naturally suggest prior misconduct by defendants.”

“Such language can only serve two purposes: either to attract attention that a correction follows, or to humiliate the advertiser … neither of which is a permissible goal under civil RICO corrective statements opinion,” the court said.

The judges suggested that “with the minor revisions mandated in this opinion, the district court can simply issue an order requiring the corrective statements remedy to go forward.”

In court filings, Reynolds, Altria Group Inc., Philip Morris USA Inc. and Lorillard Tobacco Co. have said the 2009 Tobacco Control Act eliminated any reasonable likelihood the companies would commit future violations, thus making moot the need for remedies, such as corrective statements.

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